Therapy for preventing recurrent symptoms in adults with gallstones

Clinical and cost-effectiveness of cholecystectomy versus observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis

Gallstones disease (cholelithiasis) is one of the most common and costly gastrointestinal disorders in Western countries. Approximately 15% of the adult Western population suffer from gallstones. Laparoscopic cholecystectomy has become the therapy of choice for patients with symptomatic gallstones with or without cholecystitis and the rate of surgical procedures has increased over time. In the UK, (early) cholecystectomy is commonly offered to symptomatic patients suffering from biliary colic or cholecystitis, with a significant cost to the NHS. However, a proportion of these patients do not show up for elective surgery or opt for conservative treatment. Whilst many studies have concentrated on the best timing for performing surgery and on operative outcomes and complications the question whether cholecystectomy is always required in patients with mild, uncomplicated, symptomatic gallstones has not been rigorously evaluated in a UK setting. In a recent population-based cohort study, 58% of the patients who initially presented with mild, uncomplicated symptoms and 52% of those who had severe, uncomplicated symptoms at presentation did not experience further episodes of biliary pain at medium-term follow-up. These findings indicated that symptomatic uncomplicated patients may be treated expectantly. This study includes a systematic review of the evidence for the safety and clinical and cost-effectiveness of conservative treatment versus immediate surgery, as well as de novo decision modelling to determine which management option is likely to offer the most cost-effective use of NHS resources.

Outcome and Translation

This study developed clinical care pathways for the treatment of symptomatic gallstones in a UK NHS context; summarised evidence for the clinical effectiveness and safety of observation/conservative management compared to surgery; determined the relative cost-effectiveness of the alternative option; and Identified and prioritised future research. As a result of the uncertainty surrounding the clinical and cost-effectiveness of the alternative approaches to treatment, the NIHR HTA programme subsequently commissioned a prospective trial to definitively address this question. The AoT theme is currently collaborating on this on-going study (see http://www.abdn.ac.uk/heru/research/assessment-of-technologies/techdesign/evar/).

HERU researchers involved in this research project: Mary Kilonzo and Paul McNamee

External collaborators: C Ramsay, M Brazelli, C Cruikshank, F Stewart, C Fraser, A Elders, A Avenell (HSRU, University of Aberdeen); I Ahmed, J Leeds (NHS Grampian)

Publications

Brazzelli, M., Cruickshank, M., Kilonzo, M., Ahmed, I., Stewart, F., McNamee, P., Elders, A., Fraser, C., Avenell, A. and Ramsay, C. (2014) 'Clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis: a systematic review and economic evaluation', Health Technology Assessment, 18(55).

Brazzelli, M., Cruickshank, M., Kilonzo, M., Ahmed, I., Stewart, F., McNamee, P., Elders, A., Fraser, C., Avenell, A. and Ramsay, C. (2015) 'Systematic review of the clinical and cost effectiveness of cholecystectomy versus observation/conservative management for uncomplicated symptomatic gallstones or cholecystitis', Surgical Endoscopy, 29(3), 637-647.

Kilonzo, M. (2016) 'Gallstones: wait and see or treat?', HERU Policy Brief, University of Aberdeen, April 2016.